Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction.

Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial

This study is aimed to conduct a randomised controlled trial comparing endotracheal intubation (ETI) in bed up head elevation BUHE position versus sniffing position in simulated rapid sequence induction (RSI).

Objective is to determine if the time taken for intubation in the bed up head elevated position is non-inferior to time taken for intubation in the sniffing position.

The hypotheses:

1. In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position is non inferior to time required for DL and successful ETI in the sniffing position.
2. In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position improve POGO score.
3. In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position reduces airway related complications.

Terminology:

Direct laryngoscopy (DL) and Endotracheal intubation (ETI): Is a method of inserting a breathing tube into the trachea (windpipe) once patient undergo general anaesthesia.

Bed up head elevation (BUHE): Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch.

Sniffing position: Maintaining supine position with head elevation with head rest.

Rapid sequence induction (RSI): An established method of inducing anaesthesia in patients who are at risk of aspiration of gastric contents into the lungs. It involves loss of consciousness during cricoid pressure followed by intubation without face mask ventilation. The aim is to intubate the trachea as quickly and as safely as possible.

POGO score: Percentage of glottic opening

Cricoid Pressure (CP): Maneuvre to prevent regurgitation of gastric contents during induction of anaesthesia by temporary occlusion of the upper end of the esophagus by backward pressure of cricoid cartilage against bodies of cervical vertebrae.

Study Overview

• Status: Unknown
• Conditions: Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction
• Intervention / Treatment: Other: comparison between two different intubating position

Detailed Description

All patients from age 18 years old to 75 years old undergoing elective surgery under general anaesthesia in operating theater of University Malaya Medical Centre over a period of 15 months, from April 2018 to June 2019 will be included and recruited based on inclusion and exclusion criteria.

Those patient that fulfilled the criteria and consented for the study will be randomized to 2 group.

i) BUHE group: Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch.

ii) Sniffing group: Maintaining supine position with head elevation with head rest (foam donut).

Induction of anaesthesia starts with:

• preoxygenation with 100% oxygen for 3-5 min performed until end tidal oxygen of 85% achieved.
• A pre-calculated dose of induction agent is administered, followed immediately by a neuromuscular blocking agent.

(IV Fentanyl 2mcg/kg,IV Propofol 2-3mg/kg,IV Rocuronium 1mg/kg).

• Cricoid pressure at 10 Newton is applied increasing to 30 Newton once consciousness is lost.
• After adequate neuromuscular blockade,both group patients will be intubated by one investigator via direct laryngoscopy using Macintosh blade size 3 or 4.
• Time taken from insertion of Macintosh blade into oral cavity till confirmation of endotracheal tube placement via detection of CO2 on the end tidal CO2 monitor will be recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
      • Recruiting
      • University Malaya Medical Centre
      • Contact: Shahmini Ganesh, MD; Phone Number: 0379492052; Email: shahminig2805@gmail.com
      • Contact: Samuel Tsan Ern Hung, MD; Phone Number: 0379492052; Email: samuel.tsan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old.

Exclusion Criteria:

• Patients with airway obstruction
• Patients with contraindication to neck extension
• BMI> 35kg/m2
• Patient with history of difficult airway from previous intubation history
• Only single intubation will be included if patients had multiple surgery during their hospital stay
• Patients with ischaemic heart disease, cerebrovascular diseases and respiratory disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Sniffing position; Subject will be maintained in standard intubation position which is supine position with head elevation with head rest (foam donut).
EXPERIMENTAL: Bed up head elevation position; Subject will be maintained at bed up 20-30 degree aiming alignment between the external auditory meatus with sternal notch	Other: comparison between two different intubating position; Comparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave	Measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave	Intraoperatively , during induction of anaesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of laryngoscopy and intubation attempt	Number of attempts taken by investigator to obtain successful endotracheal intubation in both arms	Intraoperatively , during induction of anaesthesia
Laryngeal exposure measured via POGO score	Percentage of glottic opening during laryngoscopy	Intraoperatively , during induction of anaesthesia
Occurrence of difficult intubation	Defined as ≥3 attempts at intubation	Intraoperatively , during induction of anaesthesia
Occurrence of hypoxia	Hypoxia defined as pulse oximetry reading less than 95 percents	Intraoperatively , during induction of anaesthesia
The use of any other airway adjunct or external laryngeal manipulation to assist in intubation	Change of blade size, bougie, magill forcep, video assisted laryngoscope,external laryngeal manipulation (Use of any airway adjunct is grouped as one)	Intraoperatively , during induction of anaesthesia
Occurrence of esophageal intubation	Unsuccessful intubation into esophagus	Intraoperatively , during induction of anaesthesia
Occurrence of airway trauma	broken tooth, bleeding or injury from oral cavity, tongue or lips, etc	Intraoperatively , during induction of anaesthesia

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Shahmini Ganesh, MD, UMMC

Publications and helpful links

General Publications

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• Smith KJ, Ladak S, Choi PT, Dobranowski J. The cricoid cartilage and the esophagus are not aligned in close to half of adult patients. Can J Anaesth. 2002 May;49(5):503-7. doi: 10.1007/BF03017931.
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• Kluger MT, Short TG. Aspiration during anaesthesia: a review of 133 cases from the Australian Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia. 1999 Jan;54(1):19-26. doi: 10.1046/j.1365-2044.1999.00642.x.
• Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology. 1995 Feb;82(2):367-76. doi: 10.1097/00000542-199502000-00007.
• Thibodeau LG, Verdile VP, Bartfield JM. Incidence of aspiration after urgent intubation. Am J Emerg Med. 1997 Oct;15(6):562-5. doi: 10.1016/s0735-6757(97)90157-1.
• Tomkinson J, Turnbull A, Robson G, Cloake E, Adelstein AM, Weatherall J. Report on confidential enquiries into maternal deaths in England and Wales 1973-1975. Rep Health Soc Subj (Lond). 1979;14:1-166. No abstract available.
• Guirro UB, Martins CR, Munechika M. Assessment of anesthesiologists' rapid sequence induction technique in an university hospital. Rev Bras Anestesiol. 2012 May-Jun;62(3):335-45. doi: 10.1016/S0034-7094(12)70134-4.
• Schmidt A, Akeson J. Practice and knowledge of cricoid pressure in southern Sweden. Acta Anaesthesiol Scand. 2001 Nov;45(10):1210-4. doi: 10.1034/j.1399-6576.2001.451006.x.
• Brimacombe J, White A, Berry A. Effect of cricoid pressure on ease of insertion of the laryngeal mask airway. Br J Anaesth. 1993 Dec;71(6):800-2. doi: 10.1093/bja/71.6.800.
• Vanner RG, Clarke P, Moore WJ, Raftery S. The effect of cricoid pressure and neck support on the view at laryngoscopy. Anaesthesia. 1997 Sep;52(9):896-900. doi: 10.1111/j.1365-2044.1997.181-az0315.x.
• Turgeon AF, Nicole PC, Trepanier CA, Marcoux S, Lessard MR. Cricoid pressure does not increase the rate of failed intubation by direct laryngoscopy in adults. Anesthesiology. 2005 Feb;102(2):315-9. doi: 10.1097/00000542-200502000-00012.
• Adnet F, Racine SX, Borron SW, Clemessy JL, Fournier JL, Lapostolle F, Cupa M. A survey of tracheal intubation difficulty in the operating room: a prospective observational study. Acta Anaesthesiol Scand. 2001 Mar;45(3):327-32. doi: 10.1034/j.1399-6576.2001.045003327.x.
• Magill IW. TECHNIQUE IN ENDOTRACHEAL ANAESTHESIA. Br Med J. 1930 Nov 15;2(3645):817-9. doi: 10.1136/bmj.2.3645.817. No abstract available.
• Isono S. Common practice and concepts in anesthesia: time for reassessment: is the sniffing position a "gold standard" for laryngoscopy? Anesthesiology. 2001 Oct;95(4):825-7. doi: 10.1097/00000542-200110000-00007. No abstract available.
• Akhtar M, Ali Z, Hassan N, Mehdi S, Wani GM, Mir AH. A Randomized Study Comparing the Sniffing Position with Simple Head Extension for Glottis Visualization and Difficulty in Intubation during Direct Laryngoscopy. Anesth Essays Res. 2017 Jul-Sep;11(3):762-766. doi: 10.4103/0259-1162.204206.
• Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.
• Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.
• Lebowitz PW, Shay H, Straker T, Rubin D, Bodner S. Shoulder and head elevation improves laryngoscopic view for tracheal intubation in nonobese as well as obese individuals. J Clin Anesth. 2012 Mar;24(2):104-8. doi: 10.1016/j.jclinane.2011.06.015. Epub 2012 Feb 1.
• Lee BJ, Kang JM, Kim DO. Laryngeal exposure during laryngoscopy is better in the 25 degrees back-up position than in the supine position. Br J Anaesth. 2007 Oct;99(4):581-6. doi: 10.1093/bja/aem095. Epub 2007 Jul 4.
• Turner JS, Ellender TJ, Okonkwo ER, Stepsis TM, Stevens AC, Eddy CS, Sembroski EG, Perkins AJ, Cooper DD. Cross-over study of novice intubators performing endotracheal intubation in an upright versus supine position. Intern Emerg Med. 2017 Jun;12(4):513-518. doi: 10.1007/s11739-016-1481-z. Epub 2016 Jun 14.
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• Hastings RH, Kelley SD. Neurologic deterioration associated with airway management in a cervical spine-injured patient. Anesthesiology. 1993 Mar;78(3):580-3. doi: 10.1097/00000542-199303000-00022. No abstract available.
• Khandelwal N, Khorsand S, Mitchell SH, Joffe AM. Head-Elevated Patient Positioning Decreases Complications of Emergent Tracheal Intubation in the Ward and Intensive Care Unit. Anesth Analg. 2016 Apr;122(4):1101-7. doi: 10.1213/ANE.0000000000001184.
• Boyce JR, Ness T, Castroman P, Gleysteen JJ. A preliminary study of the optimal anesthesia positioning for the morbidly obese patient. Obes Surg. 2003 Feb;13(1):4-9. doi: 10.1381/096089203321136511.
• Sun DA, Warriner CB, Parsons DG, Klein R, Umedaly HS, Moult M. The GlideScope Video Laryngoscope: randomized clinical trial in 200 patients. Br J Anaesth. 2005 Mar;94(3):381-4. doi: 10.1093/bja/aei041. Epub 2004 Nov 26.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2018
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: March 9, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (ACTUAL): April 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Rapid sequence induction; sniffing position; cricoid pressure; Bed up head elevation; time taken for intubation in seconds; percentage of glottic opening
• Other Study ID Numbers: MREC ID NO: 2018222-6042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data that already summarized and analysed in the form of schematic diagram will be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No